Incisionless Gastric Bypass Method And Devices

ABSTRACT

A system and method for endoscopically forming an anastomosis between two naturally adjacent points in the digestive tract. The system and method utilizes elongate magnetic devices that, when connected across a tissue boundary, necrose tissue until an anastomosis forms and the devices are passed naturally. Despite the elongate shape of the devices, the resulting anastomosis is substantially round. As such, round anastomoses can be formed having increased diameters merely by increasing the lengths of the devices, obviating the need for wider endoscopes.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 61/226,225 filed Jul. 16, 2009 entitled Incisionless Gastric BypassMethod And Devices, and to U.S. Provisional Application Ser. No.61/225,901 filed Jul. 15, 2009 entitled Incisionless Gastric BypassMethod & Devices, both of which are hereby incorporated in theirentirety herein.

BACKGROUND OF THE INVENTION

The present invention relates generally to addressing problems relatedto the digestive system, particularly obesity and type II diabetes.Additionally, it is contemplated that the methods and devices of thepresent invention may be used in treating other digestive conditionssuch as benign or malignant obstructions of the stomach, small boweland/or colon when clinically indicated; peptic ulcer disease;inflammatory bowel disease; adhesions; annular pancreas; duodenal,pancreatic, intestinal, or colonic primary malignancies; and secondarymalignancies.

Obesity

According to the Center for Disease Control (CDC), sixty six percent ofthe United States population are overweight, and thirty two percent areobese, presenting an overwhelming health problem. From an economicstandpoint, it is estimated that more than 100 billion dollars are spenton obesity and treating its major co-morbidities. This figure does notinclude psychological and social costs. Many health care expertsconsider obesity the largest health problem facing westernized societiesand consider obesity an epidemic. From a medical standpoint, obesity isthe primary risk factor for type 2 diabetes and obstructive sleep apnea.It increases the chances for heart disease, pulmonary disease,infertility, osteoarthritis, cholecystitis and several major cancers,including breast and colon cancers. Despite these alarming facts,treatment options for obesity remain limited.

Treatment options include dietary modification, very low-calorie liquiddiets, pharmaceutical agents, counseling, exercise programs and surgery.Diet and exercise plans often fail because most individuals do not havethe discipline to adhere to such plans. When diet and exercise fail,many try dietary supplements and drugs or other ingestible preparationspromoted as being capable of suppressing appetite or inducing satiety.In general, these techniques for treating compulsive overeating/obesityhave tended to produce only a temporary effect. The individual usuallybecomes discouraged and/or depressed after the initial rate of weightloss plateaus and further weight loss becomes harder to achieve. Theindividual then typically reverts to the previous behavior of compulsiveovereating.

Surgical procedures that restrict the size of the stomach and/or bypassparts of the intestine are the only remedies that provide lasting weightloss for the majority of morbidly obese individuals. Surgical proceduresfor morbid obesity are becoming more common based on long-termsuccessful weight loss result.

Bariatric surgery is a treatment for morbid obesity that involvesalteration of a patient's digestive tract to encourage weight loss andto help maintain normal weight. Known bariatric surgery proceduresinclude jejuno-ileal bypass, jejuno-colic shunt, biliopancreaticdiversion, gastric bypass, Roux-en-Y gastric bypass, gastroplasty,gastric banding, vertical banded gastroplasty, and silastic ringgastroplasty. A more complete history of bariatric surgery can be foundon the website of the American Society for Bariatric Surgery athttp://www.asmbs.orq, the contents of which are incorporated byreference herein in their entirety.

The surgeries which create malabsorption, such as the by-passoperations, although effective in weight reduction, involve permanentmodification of the GI tract and have a risk of short and long termcomplication and even death.

Gastric bypass is the most common weight loss operation in the UnitedStates. This procedure reduces the size of the stomach and shortens theeffective-length of intestine available for nutrient absorption. Withgastric bypass many investigators have reported weight loss results thatexceed 70% of excess weight. However, this efficacy does not comewithout complication. The accepted mortality of the procedure is 1 in200. Additionally, because various sections of the intestine areresponsible for absorbing various nutrients from the chyme beingdigested, bypassing sections of the intestine can result in an inabilityof the modified digestive tract to benefit from certain nutrients. Incertain cases, this results in conditions such as anemia and must betreated with high doses of vitamin or nutrient supplements.

Diabetes

According to the National Institute of Diabetes and Digestive and KidneyDiseases (NIDDK) an estimated 20.8 million people in the United States,7.0 percent of the population, have diabetes, a serious, lifelongcondition. Of those, 14.6 million have been diagnosed, and 6.2 millionhave not yet been diagnosed. In 2005, about 1.5 million people aged 20or older were diagnosed with diabetes. According to the AmericanDiabetes Association, the total annual economic cost of diabetes in 2002was estimated to be $132 billion.

Diabetes is a set of related diseases in which the body cannot regulatethe amount of sugar (glucose) in the blood. Glucose in the bloodprovides the body with energy. In a healthy person, the blood glucoselevel is regulated by several hormones including insulin, glucagons, andepinephrine. Insulin is produced by the pancreas, a small organ near thestomach that also secretes important enzymes that help in the digestionof food. Insulin allows glucose to move from the blood into the liver,muscle, and fat cells, where it is used for fuel.

At least 90% of patients with diabetes have Type 2 diabetes wherein thepancreas secretes insulin but the body is partially or completely unableto use the insulin. This is sometimes referred to as insulin resistance.The body tries to overcome this resistance by secreting more and moreinsulin. People with insulin resistance develop Type 2 diabetes whenthey do not continue to secrete enough insulin to cope with the higherdemands.

Recently, evidence for reduction of complications of type 2 diabeteswith tight control of hyperglycemia has been reported, but currenttherapies, including diet, exercise, behavior modification, oralhypoglycemic agents, and insulin, rarely return patients to euglycemia.

For reasons not completely known, the majority of patients who undergogastric bypass surgery experience resolution of Type 2 diabetes andenjoy normal blood glucose and glycosylated hemoglobin levels withdiscontinuation of all diabetes-related medications. One hypothesis,that has been proposed, is that diabetes control results from theexpedited delivery of nutrient-rich chyme (partially digested food) tothe distal intestines, enhancing a physiologic signal that improvesglucose metabolism, the so called “hindgut hypothesis”. However, becausegastric bypass surgery is considered a relatively high-risk majorsurgery, it is not used to treat Type 2 diabetes.

OBJECTS AND SUMMARY OF THE INVENTION

The methods and devices of the present invention are primarily directedto a minimally invasive, endoscopic solution for treating patients withobesity and/or Type 2 diabetes. The methods and devices can also be ofbenefit in laparoscopic and open surgical procedures. The solution issimple, user-friendly, reversible, and does not require a permanentimplant. When the procedure is performed endoscopically, the need forabdominal incisions is eliminated. Thus, the procedure has the potentialof being performed outside of the operating room, potentially in anendoscopy suite.

One aspect of the present invention treats the aforementioned conditionsby creating a partial bypass of a portion of the small intestines.Preferably, an anastomosis is created between the distal portion of thesecond section and/or third section of the duodenum and the ileum orcolon. Using anatomical landmarks as reference, the anastomosis shouldpreferably be positioned in the duodenum distal to the hepatopancreaticampulla where the common bile and main pancreatic duct empty into theduodenum and proximal to the point where the superior mesenteric arteryand vein cross over the duodenum.

This solution creates an alternative pathway for chyme. A portion of thenutrients will bypass a portion of the small intestines and thus not beabsorbed (controlled absorption). The amount of bypass is controlled bythe size of the anastomosis. The physician is thus able to vary the sizeof the anastomosis both at the time of the procedure and duringsubsequent follow-up procedures. The anastomosis also provides a bypassfor nutrient-rich chyme to enter the ileum or colon. This is thought tohave the effect of triggering early satiety as well as improving glucosemetabolism. A potential candidate mediator of this effect isglucagon-like peptide 1 (GLP-1). This incretin hormone is secreted bycells in the distal bowel in response to nutrients, which stimulatesinsulin secretion.

Another aspect of the present invention provides a method by which anendoscope is inserted orally and advanced through the upper GI track andthen into the duodenum. Another endoscope is inserted anally andadvanced into the colon or ileum. The normal anatomy in a human is suchthat the second and third sections of the duodenum are in closeproximity with portions of the ileum and colon. If either structure isilluminated from within, it can readily be seen from the other. Forexample, if the duodenum is illuminated, the light can be seen with anendoscope in the ileum or colon and the ileum or colon can then begently maneuvered such that it is touching the duodenum. The ileum orcolon can also be positioned by visualizing the endoscopes usingfluoroscopic imaging and maneuvering the endoscope within the ileum orcolon to close proximity of the endoscope in the duodenum.

Once intimate contact has been confirmed between the duodenum and theileum or colon, magnets that have been pre-attached to the endoscope arecoupled. In another embodiment of the invention magnets are passedthrough the working channel of the endoscope rather than pre-attached.Once the magnets have been magnetically coupled and alignment isverified utilizing endoscopic and/or fluoroscopic imaging, they arereleased from the endoscopes. The two coupled magnets create intimatecontact between the serosal surfaces of the two vessels. During thehealing period the tissue between the magnets is compressed and becomesnecrotic. The tissue near the outside of the anastomosis device iscompressed at a lower force. This tissue forms a region or ring ofhealed tissue. After a few weeks the necrotic tissue, along with themagnetic implants detach and are expelled. There is no flow betweenvessels during the healing period. Everything flows through the naturaldistal duodenum and thus there is no risk of obstructing flow. Humanserosal tissue that is placed in intimate contact has been shown to healwithin 7 days.

Patients can be tracked and if absorption needs to be further limited afollow up procedure can be performed to create additional anastomosis inthe same or other locations or make the anastomosis larger. Likewise, ifthe anastomosis is too large, it may be modified by closing a portion ofthe anastomosis with an endoluminal suturing, stapling, or clip device.The procedure may be completely reversed by closing the entireanastomoisis with such devices.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-5 are views of the digestive system showing a progression ofsteps of an embodiment of a method of the present invention for creatinga duodenum to colon anastomosis;

FIG. 6 is a partial view of the digestive system with an anastomosisformed by an embodiment of a method of the present invention;

FIGS. 7-10 are views of the digestive system showing a progression ofsteps of an embodiment of a method of the present invention for creatinga partial bypass with a side-to-side anastomosis between the duodenumand ileum;

FIG. 11 a is a perspective view of an embodiment of a device of thepresent invention attached to an embodiment of a delivery device of thepresent invention;

FIG. 11 b is a perspective view of the device of FIG. 11 a beingreleased from the delivery device of FIG. 11 a;

FIG. 12 a is an end view of an embodiment of a device of the presentinvention attached to an embodiment of a delivery device of the presentinvention;

FIG. 12 b is a section view taken along lines A-A of FIG. 12 a;

FIG. 13 is a plan view of an embodiment of a device of the presentinvention attached to an embodiment of a delivery device of the presentinvention;

FIG. 14 is an elevation of an embodiment of a device of the presentinvention attached to an embodiment of a delivery device of the presentinvention;

FIG. 15 is a side elevation of a pair of devices of an embodiment of thepresent invention being implanted in adjacent body lumens to form ananastomosis therebetween;

FIG. 16 a is a perspective view of an embodiment of a device of thepresent invention attached to an embodiment of a delivery device of thepresent invention;

FIG. 16 b is a perspective view of the device of FIG. 16 a beingadvanced from a distal end of the delivery device of FIG. 16 a;

FIG. 16 c is a perspective view of the device of FIG. 16 a beingreleased from the delivery device of FIG. 16 a;

FIG. 17 a is an end view of an embodiment of a device of the presentinvention attached to an embodiment of a delivery device of the presentinvention;

FIG. 17 b is a section view taken along lines B-B of FIG. 17 a;

FIG. 18 a is a perspective view of an embodiment of a device of thepresent invention attached to an embodiment of a delivery device of thepresent invention;

FIG. 18 b is a perspective view of the device of FIG. 18 a beingadvanced from a distal end of the delivery device of FIG. 18 a;

FIG. 18 c is a perspective view of the device of FIG. 18 a beingreleased from the delivery device of FIG. 18 a;

FIG. 19 is a detail view of area A of FIG. 18 b;

FIG. 20 is a detail view of area B of FIG. 18 c;

FIG. 21 a is an end view of an embodiment of a device of the presentinvention attached to an embodiment of a delivery device of the presentinvention;

FIG. 21 b is a section view taken along lines C-C of FIG. 21 a;

FIG. 21 c is a section view taken along lines D-D of FIG. 21 a;

FIG. 22 is a cutaway view of an embodiment of a device of the presentinvention loaded into an embodiment of a delivery device of the presentinvention;

FIG. 23 a is a perspective view of an embodiment of a device of thepresent invention attached to an embodiment of a delivery device of thepresent invention;

FIG. 23 b is a perspective view of the device of FIG. 23 a beingreleased from the delivery device of FIG. 23 a;

FIG. 24 a is a perspective view of an embodiment of a device of thepresent invention attached to an embodiment of a delivery device of thepresent invention;

FIG. 24 b is a perspective view of the device of FIG. 24 a beingadvanced from a distal end of the delivery device of FIG. 24 a;

FIG. 24 c is a perspective view of the device of FIG. 24 a beingreleased from the delivery device of FIG. 24 a;

FIG. 24 d is a detail view of area C of FIG. 24 c;

FIG. 25 is a comparison of device shapes and resulting anastomosisshapes.

FIG. 26 is a perspective view of an embodiment of a delivery device ofthe present invention being used to deliver an arrangement of twodevices according to an embodiment of the present invention;

FIG. 27 is a perspective view of an embodiment of a delivery device ofthe present invention being used to deliver an arrangement of twodevices according to an embodiment of the present invention;

FIG. 28 is a perspective view of an embodiment of a delivery device ofthe present invention being used to deliver an arrangement of fourdevices according to an embodiment of the present invention;

FIGS. 29 a-d are a progression of perspective views of an embodiment ofa delivery device of the present invention releasing an embodiment of adevice of the present invention;

FIG. 30 a is a perspective view of an embodiment of a device of thepresent invention attached to an embodiment of a delivery device of thepresent invention;

FIG. 30 b is a perspective view of the device of FIG. 30 a beingadvanced from a distal end of the delivery device of FIG. 30 a;

FIG. 30 c is a perspective view of the device of FIG. 30 a beingreleased from the delivery device of FIG. 30 a;

FIG. 31 a is a perspective view of an embodiment of a device of thepresent invention attached to an embodiment of a delivery device of thepresent invention;

FIG. 31 b is a perspective view of the device of FIG. 31 a beingadvanced from a distal end of the delivery device of FIG. 31 a;

FIG. 31 c is a perspective view of the device of FIG. 31 a beingreleased from the delivery device of FIG. 31 a;

DETAILED DESCRIPTION OF THE EMBODIMENTS

The invention provides for the method and device apparatus to create apartial bypass between the duodenum and ileum or duodenum and colonutilizing a completely incisionless endoscopic method using both themouth and anus as natural pathways for gaining access to the preferredanastomosis location. An important aspect of the invention is that theanastomosis is created between naturally adjacent or close proximitysections of the duodenum and ileum or duodenum and colon, thereforeallowing a means for a totally incisionless procedure. The inventiongenerally involves inserting a first endoscopic delivery device orallyinto the duodenum. A similar second endoscopic delivery device isinserted anally into the colon or the ileum to a position where thetracts of the ileum or colon naturally lie adjacent or in closeproximity to the duodenum. Having been pre-assembled at the distal tipof the endoscopic delivery device or advanced through a channel of theendoscope or overtube, the magnetic implants are subsequently alignedand magnetically coupled. The implant devices are magnetically attractedto each other (one or both being magnets) and are aligned to one anotherusing visual and/or fluoroscopic guidance and released from theirrespective deployment devices. The magnetic implants apply force to thevessel walls trapped between them and pressure necrosis preferablyresults within a few weeks. The circumferential tissue near the edge ofthe magnetic devices is of lower pressure and creates a healedcontinuous region of tissue between the vessels. After an appropriateperiod of time, the coupled magnetic devices and compressed necrotictissue detach from the surrounding tissue therefore creating ananastomosis. Subsequently, the magnetic implants pass through thedigestive tract leaving no permanent implant in the body. A first seriesof device embodiments of the invention illustrate using magneticimplants that are pre-assembled to the distal tip of the endoscope. Asecond series of embodiments of the invention illustrates using magneticimplants that are advanced through the working channel of an endoscopeinstead of pre-assembled at the distal tip. A third series ofembodiments illustrates releasably attaching the magnetic devices to anovertube that surrounds the endoscope as well as advancing the devicesthrough a lumen within the wall of an overtube.

As shown in FIG. 1, the digestive tract 10 includes the esophagus 12,which empties into the stomach 14. Distal to the stomach is the smallintestine, which is comprised of the duodenum 16, jejunum 18, and ileum20 sections. The ileum 20 empties into a part of the colon 22 called thececum. The colon generally consists of five main segments: ascending 22a, transverse 22 b, descending 22 c, sigmoid 22 d, and rectum 22 e.

FIG. 6 shows the various segments of the duodenum and anatomicallandmarks within and around the duodenum. The duodenum consists of foursegments: superior 16 a, descending 16 b, horizontal 16 c, and ascending16 d. In this figure, a section of the transverse colon has been removedto view the anatomical landmarks near the duodenum more clearly.Generally, the common bile and pancreatic ducts combine into thehepatopancreatic ampulla 24 which empties into the descending duodenum16 b approximately two-thirds along its length. The superior mesentericartery and vein 26 cross the horizontal duodenum segment 16 c at itsdistal end.

Although an anastomosis could be made anywhere in the duodenum to theileum or colon, the preferred duodenal location for the anastomosis 28is in the distal third of the descending segment 16 b and/or thehorizontal segment 16 c of the duodenum, provided that the anastomosisis distal to the hepatopancreatic ampulla 24 and proximal of thesuperior mesenteric artery and vein 26. Creating the anastomosis distalto the common bile and pancreatic ducts will allow their contents toflow in the newly created partial bypass as well as in the originalnatural tract. Positioning the anastomosis proximal of the supereriormesenteric artery and vein provides many benefits: 1) access is easierthan going more distal, 2) the malabsorptive effect will be enhancedfrom bypassing the duodenum more proximally, 3) the position is idealfor connecting the duodenum to naturally adjacent segments of the colonand ileum, and 4) connecting proximal of the superior mesenteric arteryand vein avoids potential complications of placing devices on ordirectly adjacent the wall of the superior mesenteric artery and vein.

Referring to FIGS. 1 and 6 for the duodenum to colon side-to-sideanastomosis, the invention takes into account that the transverse colon22 b naturally lies on top of (superior) the preferred location in theduodenum 28 as described above, in which, the superior wall of theduodenum is adjacent the posterior wall of the transverse colon 22 b.Creating an anastomosis between naturally adjacent tracts simplifies theprocedure of accessing the anastomosis sites and aligning theanastomosis devices into correct position. This is especially evidentfor a duodenum to transverse colon anastomosis as it is of commonpractice and skill level for endoscopists to access these locations inthe digestive tract. Although advanced access tools such as single ordouble balloon enteroscopy may be used, this anastomosis location allowsthe use of standard endoscopic devices to access the duodenum andtransverse colon.

A first endoscopic delivery device 30 a is inserted orally and advancedthrough the esophagus 12, stomach 14, and into the duodenum 16. Theendoscopic delivery device 30 a consists of a pre-assembled endoscope 32a, delivery catheter 34 a, and magnetic implant 36 a. The magneticimplant 32 a is releasably attached to the distal tip of the deliverycatheter 34 a which has been loaded into a working channel of theendoscope 32 a.

Similarly, a second endoscopic delivery device 30 b is inserted throughthe anus 22 f and advanced into the transverse colon 22 b. In similarfashion, the endoscopic delivery device 30 b consists of a pre-assembledendoscope 32 b, delivery catheter 34 b, and magnetic implant 36 b. Themagnetic implant 32 b is releasably attached to the distal tip of thedelivery catheter 34 b which has been loaded into a working channel ofthe endoscope 32 a.

Once the first 30 a and second 30 b endoscopic delivery devices areroughly positioned into the duodenum 16 and transverse colon 22 b asshown in FIG. 1, the operator should confirm that the endoscopes are inadjacent vessels with close proximity. This may be accomplished byvisualizing the light source emitted from the first endoscope by thesecond endoscope. For example, the light source emitted by the endoscope32 a in the duodenum 16 should be easily viewed by the endoscope 32 b inthe transverse colon 22 b and vise-versa. Additionally, or instead ofthe light source, the position of the first endoscope to the second maybe verified by visualizing the first endoscope touching and moving thewall of the vessel of the second endoscope. For example, the firstendoscope 32 a in the duodenum 16 may be articulated to touch anddisplace the wall of both the duodenum and the adjacent wall of thetransverse colon. The second endoscope in the transverse colon 22 bwould view the resulting wall motion to confirm the proximity of thefirst endoscope in the duodenum. An additional and preferred method ofconfirming that the endoscopes are in adjacent vessels of closeproximity is to use fluoroscopy to confirm the position and aid inguiding the magnetic implants into their final coupled position. Forexample, if the distal end of the roughly positioned endoscopic deliverydevice 30 a in the duodenum 16 is not in close proximity and adjacent tothe distal end of the endoscopic delivery device 30 b in the transversecolon 22 b, fluoroscopy may be used to articulate the distal tip of theendoscopic delivery devices and their respective vessels into finalposition. This is accomplished by manipulating and articulating theendoscopes 32 a and 32 b, the delivery catheters 34 a and 34 b, and/orthe magnetic implant 36 a and 36 b. The delivery catheter 34 is designedto move axially within the working channel of the endoscope 32 and mayalso be designed so that its distal tip may articulate the attachedmagnetic implant 36. The magnetic implant 36 may be positioned axiallyor radially by advancing or rotating the delivery catheter 34 relativeto the endoscope 32. Contrast may be injected into the duodenum 16 andtransverse colon 22 b during fluoroscopy to visualize the vessels andhelp bring them into proximity to one another by articulating andmanipulating the devices. Once brought into close proximity, themagnetic implants will couple and self align as shown in FIG. 2. Oncecoupled, the magnetic implant in the duodenum should be visuallyinspected to make sure it is in the preferred position 28 as describedpreviously and shown in FIG. 6. Additionally, fluoroscopy may be used toverify that the magnetic implants are properly oriented and contrast maybe injected to show that the vessels remain adjacent and are notadversely twisted. If the magnetic implants are not properly aligned orthe vessel wall has been adversely deformed, the magnetic implants maybe pulled apart and repositioned using the same techniques as describedabove. Once the operator is satisfied with the positioning of themagnetic implants and vessel geometry, the coupled magnetic implants 36a and 36 b are released from their respective delivery catheters 34 aand 34 b and the endoscopic delivery devices are removed from the body.If the implants need to be repositioned or removed after release, it ispreferable that the implants could be easily recaptured using the sameendoscopic delivery devices.

FIG. 3 shows a lateral view of FIG. 2 of the coupled magnetic implants36 a and 36 b after they have been released from the delivery catheters34 a and 34 b. The magnetic implants 36 a and 36 b compress the duodenaland colon wall between them which results in ischemic pressure necrosisof the tissue trapped between them. The surrounding circumferentialtissue is compressed at a lower force and results in a healed continuousregion or ring of tissue between the vessels around the magneticimplants. After an appropriate period of time, the coupled magneticimplants and compressed necrotic tissue detach from the surroundingtissue and therefore create an anastomosis. Once detached, the implantspass through the digestive tract, leaving no device in the body. FIG. 4illustrates the anastomosis after the magnetic implants have detachedfrom the surrounding tissue and are about to start their journey out ofthe digestive tract. FIG. 5 shows the preferable path the magneticimplants take to be eliminated from the digestive tract. No permanentimplant is left in the body. Although not ideal, the magnetic implantsmay start their journey by traveling down the duodenum instead of thecolon side of the anastomosis. This may take longer for the implants toexit the body as they are taking a longer pathway. It is alsocontemplated that if they initially started down the duodenum (longpath) that once they reach the colon side of the anastomosis that theycould pass through the anastomosis and travel down the duodenum side asecond time.

Notice in FIG. 4 and FIG. 5 the resulting anastomosis creates a partialbypass where chyme may take one of two paths: 1) the original naturalpath through the duodenum and on to the jejunum or 2) the new pathcreated with the anastomosis to the transverse colon 22 b. It is theobject of this invention to leave the original natural path in place sothat chyme, bile, and other digestive juices may travel down both paths.Chyme that takes the new path will bypass a portion of the smallintestines and therefore not be absorbed. The ratio of chyme goingthrough the new path may be dependent on the size of the anastomosisrelative to the original vessel size. The size of the anastomosis may betailored by the physician at the time of the procedure and duringsubsequent follow-up procedures. For example, if the first anastomosiswas not large enough to create the desired effect, the physician couldenlarge the first anastomosis with another device or create a secondanastomosis preferably after the first anastomosis device had exited thebody. Alternatively, if the first anastomosis was too large or theprocedure needed to be reversed, the physician could partially orcompletely close the anastomosis with a transluminal suturing, stapling,or clip device. The anastomosis also provides a bypass for nutrient-richchyme to enter the ileum or colon. This is thought to have the effect oftriggering early satiety as well as improving glucose metabolism. Apotential candidate mediator of this effect is glucagon-like peptide 1(GLP-1). This incretin hormone is secreted by cells in the distal bowelin response to nutrients, which stimulates insulin secretion.

The present invention also contemplates a duodenum to ileum anastomosis,taking into account that a portion of the ileum 20 naturally liesadjacent or in close proximity to the preferred location in the duodenum28 as described above. Although the ileum is a more difficult region toaccess than the transverse colon from the large intestines, usingadjacent tracts will simplify locating and aligning the duodenum andileum vessels and magnetic anastomosis devices to one another. Advancedaccess tools such as single and double balloon enteroscopy devices maybe used to access this location. It is preferable that an anastomosisdevice and delivery system work in conjunction with advanced accesstools and techniques.

It should also be noted that use of the term “adjacent to” or “in closeproximity to” as used herein accounts for anatomical variations, whichmay account for a separation of up to a few inches. It is well withinthe scope of the present invention to use the distal ends of theprobes/endoscopes to move the digestive tract slightly to establish amagnetic connection. Notably, unlike prior art references that puncturethe digestive tract with additional probes in order to manipulateanatomy while establishing connections (see e.g. U.S. Patent Publication2008/0208224 to Surti et al.), the devices and methods of the presentinvention have been found to easily manipulate portions of the digestivetract significant distances by simply advancing the probes/endoscopesinto the lumen walls of the bowels. Hence, it is contemplated that thepresent invention encompasses doing so, preferably without making asingle incision or puncture through patient tissue.

FIGS. 7-10 show in stepwise fashion an incisionless method for creatinga partial bypass with a side-to-side anastomosis between the duodenum 16and ileum 20. A first endoscopic delivery device 30 a is inserted orallyand advanced through the esophagus 12, stomach 14, and into the duodenum16. The endoscopic delivery device 30 a consists of a pre-assembledendoscope 32 a, delivery catheter 34 a, and magnetic implant 36 a. Themagnetic implant 36 a is releasably attached to the distal tip of thedelivery catheter 34 a which has been assembled into a working channelof the endoscope 32 a.

A second endoscopic delivery device 30 b is inserted through the anus 22f, advanced into the ascending colon 22 a, and further advanced into theileum 20. In similar fashion, the endoscopic delivery device 30 bconsists of a pre-assembled endoscope 32 b, delivery catheter 34 b, andmagnetic implant 36 b. The magnetic implant 36 b is releasably attachedto the distal tip of the delivery catheter 34 b which has been loadedinto a working channel of the endoscope 32 b.

The rough position of the magnetic implants 36 a and 36 b and vessels 16and 20 are respectively confirmed and finely positioned using the samemethod as described previously. FIG. 8 shows the magnetic implants 36 aand 36 b coupled together after the vessels are positioned appropriatelyaccording to the previously described method. FIG. 9 shows the magneticimplants 36 a and 36 b after they have been released from the deliverycatheters 34 a and 34 b. The magnetic implants apply force for a periodof time sufficient for pressure necrosis to create the anastomosis. FIG.10 illustrates the anastomosis after the magnetic implants 36 a and 36 bhave detached from the surrounding tissue and are about to start theirjourney out of the digestive tract. FIG. 10 also shows the preferablepath the magnetic implants take to be eliminated from the digestivetract. No permanent implant is left in the body. Although not ideal, themagnetic devices may start their journey by traveling down the duodenuminstead of the ileum side of the anastomosis. This may take longer forthe implants to exit the body as they are taking a longer pathway. It isalso contemplated that if they initially started down the duodenum (longpath) that once they reach the ileum side of the anastomosis that theycould pass through the anastomosis and travel down the duodenum a secondtime. As described previously, the anastomosis size may be subsequentlyaltered in a second procedure.

The devices used to deploy and create the anastomoses in the previouslydescribed methods for creating a partial bypass between the duodenum andtransverse colon and duodenum to ileum will now be explained in greaterdetail. For simplicity, most of the figures will only show one device ineach figure, however, it is assumed that a second, preferably nearlyidentical, device will be needed to create the anastomosis as shown inthe methods previously described for creating a duodenum to ileum orcolon anastomosis. The endoscope used in the embodiments may bedifferent if deploying a magnetic implant in the upper gastrointestinaltract such as the duodenum than an implant deployed in the ileum orcolon. For example, a gastroscope may be used with the devices deliveredinto the duodenum and a colonoscope may be used with devices deliveredinto the colon or ileum. Also, the magnet in the second device will beassembled in the opposite polarity from the first so that the first andsecond implant attract instead of repel each other. Although not an allinclusive list, many embodiments will be described so that those skilledin the art will appreciate that variations upon these embodiments arewithin the spirit of the invention.

FIG. 11 a shows an embodiment of a device usable to carry out themethods described previously, in that, the endoscopic delivery device 30consists of a pre-assembled endoscope 32, delivery catheter 34, andimplant 36. The delivery catheter 34 is loaded into the working channel38 of the endoscope 32 and the implant 36 is releasably attached to thedistal end of the delivery catheter 34 using a snare 42 that is wrappedaround a knob feature 40 integral to the magnetic implant 36. Theimplant 36 is docked onto the delivery catheter 34 by applying tensionto the snare wire 42 relative to the delivery catheter and locking thewire relative to the delivery catheter in a handle set that would bepositioned at the proximal end of the delivery catheter.

The implant 36 is used in conjunction with a second implant 36. The twoimplants 36 are attracted to each other magnetically, at least one ofwhich being a magnet. Hence, as used hereinafter when describing theremaining device embodiments, each implant will be referred to as amagnetic implant. This is to be interpreted as meaning the implantcontains a magnet or an element that is attracted to a magnet and shouldnot be interpreted as being limited to only magnets.

FIG. 11 b illustrates unlocking the snare wire 42 and releasing themagnetic implant 36. The snare 42 is preferably formed of braidedstainless steel cable or nitinol wire so that when the snare is unlockedto release the magnetic implant 36 it grows to a pre-formed size so thatit may be easily released from the knob 40. Once the implants have beenreleased, the snare may also be used to recapture the implant byre-snaring the knob on the implant. Although an external means forreleasably attaching the implant to the delivery catheter using a knobfeature has been shown, an implant housing is contemplated with internalreleasable attachment features. The implants may be pulled apart bypulling on the delivery catheter. Once pulled apart, they may berepositioned or removed from the body.

FIG. 12 shows a cross section of the distal portion of the endoscopicdelivery device 30 in its locked condition. The magnetic implant 36consists of a magnet 44 and housing 46. The housing consists of a top 48a and bottom 48 b. The top 48 a contains a knob feature 40 for holdingonto the magnetic implant 36 with a snare 42. The magnetic implantincorporates rounded atraumatic features for ease of tracking the devicethrough the body lumen prior to coupling and after the anastomosis hasbeen created when the magnetic device/implant is exiting the body. Themagnetic implant is preferably longer than it is wide and attached tothe delivery catheter 34 so that the length is axially aligned with theendoscope 32. This small profile of the device relative to the profileof an endoscope aids in tracking the device ahead of the endoscope andallows variable length devices to be used depending on the size ofanastomosis required. Additionally, the alignment of the magneticimplant aids in creating a side-to-side implant coupling and resultinganastomosis between vessels that are in close proximity or adjacent andaligned as shown in FIG. 15.

FIGS. 13-15 illustrate the movement and flexibility of the deliverycatheter 34. The delivery catheter may move axially and be rotatedrelative to the endoscope 32. Having the ability to telescope out of theendoscope and rotate the magnetic implant 36 may allow the operator easeof accessing the target locations within the body as well as finelypositioning the vessels and magnetic implants both axially and radiallyfor coupling. As shown in FIG. 15, in this embodiment the deliverycatheter 34 a and attached magnetic implant 36 a lead the endoscope 32 aas it is tracked through the body vessel. Therefore, it may beadvantageous if the distal tip of the delivery catheter is steerable toaid in tracking of the devices through the digestive tract. FIG. 13shows a delivery catheter which articulates the magnetic implant in onedirection while FIG. 14 shows a delivery catheter that articulatesapproximately orthogonal to the direction shown in FIG. 13. The cathetermay be fabricated to have no articulation, or articulation in onedirection, or articulation in the orthogonal direction, or both. Thedelivery catheter 34 preferably has excellent torsional stiffness sothat it can rotate the magnetic implant 36 yet is flexible enough toallow the implants to easily attract and couple together.

For example, FIG. 15 shows two magnetic implants 36 a and 36 b coupledtogether in adjacent vessels. The figure shows that the axes of theendoscopes 32 a and 32 b are not aligned with the axis of the magneticimplants 36 a and 36 b. This is possible because the delivery catheters34 a and 34 b are flexible and conform to the coupled magnetic implants36 a and 36 b. The torsional stiffness and flexibility of the deliverycatheter 34 may aid the operator with aligning and coupling the magneticimplants 36 so that the more rigid endoscopes do not have to beperfectly aligned in order for the magnetic implants 36 a and 36 b tocouple. However, the flexibility of the endoscopes may be adequate toaid in coupling of the magnetic implants 36 and it may not be necessaryto have a flexible catheter 34 to aid in coupling. The deliverycatheters 34 preferably have good tensile strength so that they caneasily pull the magnetic implants 36 apart should they need to berepositioned or removed. The delivery catheters 34 are preferably formedusing standard component guide catheter techniques and may beconstructed of a lamination of a Teflon liner, a high density stainlesssteel braid, and a polymer outer jacket. The delivery catheter may becoated with a lubricious coating to aid in advancing down the lumen ofthe endoscope and in the body vessel. Also, the implant may be coatedwith a lubricious coating to aid in advancing through the body vessel.The coating may be a silicone or hydrophilic coating.

Since the size of the anastomosis may affect the results of the partialbypass on weight loss or diabetes resolution, it is advantageous that awide range of magnetic implant sizes are available to meet the needs ofthe range of sizes of human vessel anatomy. One aspect of the inventionis that the resulting anastomosis size and shape is governed by themagnetic implant circumference and not necessarily its shape. As shownin FIG. 25 for example, if an anastomosis size of approximately 1.5″diameter was required, the operator could implant a round magnet 50 witha 1.5″ diameter and a resulting approximately round anastomosis 52 of1.5″ diameter would result after healing was complete. However, trackinga round magnet 50 that was not collapsible through the digestive systemwould prove difficult as most endoscope diameters are approximately 0.5inches by comparison. Alternatively, an approximately 1.85″ long×0.375″wide magnet 54 of equal circumference to the round magnet 50 couldeasily be tracked through the digestive system if the long end of themagnet was aligned and advanced axially ahead of the endoscope. Thisimplant would also create an approximately round anastomosis 56 of 1.5″diameter after healing was complete because even though the coupledmagnetic implants will create a necrotic core of tissue the same sizeand shape as the magnets, the body over time remodels the shape of theimplant to the native vessel shape which is approximately round. Hence,as the circumference of an elongate, relatively rectangular magnethaving a width (w) and a length (l)=2(w)+2(l), and the circumference ofa relatively round anastomosis has a circumference=2Πr. Therefore for agiven desired implant width (w), the implant length (l) required to makean anastomosis having a desired radius (r) becomes Πr−w. With this inmind, typical endoscope working channels range in inner diameter from1.5 mm to 7 mm. Thus, the magnetic implant widths (w) preferably fallwithin this range and, given the application discussed herein, and themost common endoscopes on the market, more preferably fall within therange of 1.5 mm to 3.7 mm.

Returning to FIG. 12, the magnet 44 is preferably a neodymium rare earthmagnet. The magnetic poles are aligned through the thickness of themagnet so that the maximum magnetic force is achieved when the magneticimplants 36 a and 36 b are coupled as shown in FIG. 15. The bottom ofthe housing 48 b can be smooth or have a surface roughness as themagnetic implants will align in either case because the inner lining ofthe vessels are very lubricious. Although lubricious, a rough surface onthe bottom of the housing 48 b may be advantageous once the magnets arecoupled to prevent them from decoupling due to shear forces. Themagnetic implant 36 may contain one magnet as shown in FIG. 12 ormultiple smaller magnets. The housing 46 may be larger than the magnet44 to distribute the magnetic force over a larger area. The housing 46may be formed out of metal such as stainless steel, titanium, or othermedical implant grade metals. Alternatively, the housing may be made ofsilicone or other medical implant grade polymers. Sections of thehousing may be made out of biodegradable material. For instance, theknob 40 may be overmolded with biodegradable material onto the housingso that the knob would biodegrade after the magnetic implants arecoupled. This would create a smaller profile of the coupled magneticimplants and may be easier to pass through the body once the anastomosisis created. The housing 46 may be formed of a top 48 a and bottom 48 bpiece as shown or may be one integral body if formed using moldingtechniques. The housing's main functions are to provide a protectivecoating around the magnetic so that is does not corrode should it crackor fracture, provide attachment means to hold onto the magnet,distribute the force of a magnet over a surface area, and provide anatraumatic surface that passes easily through the digestive system.Although not preferred, a magnetically attracted ferrous metal core maytake the place of the magnets in one of the magnetic implants. Forinstance, using FIG. 15 as a reference, the magnetic implant 36 a maycontain a neodymium magnet 44 a while the second implant 36 b maycontain a magnetically attracted ferrous metal core instead of aneodymium magnet 44 b as shown in FIG. 15. The ferrous metal core wouldpreferably be the same size and shape as the neodymium magnet itreplaces.

FIGS. 16 a-16 c show an alternative embodiment of an endoscopic deliverydevice 130 used according to the methods described previously to createa duodenum to transverse colon or ileum anastomosis. This embodiment issimilar to the previous embodiment except that the magnetic implantgeometry has changed to allow the implant to attach to the side of theendoscope while accessing the target anastomosis location. FIG. 16 ashows a magnetic implant 136 docked to the end of an endoscope 132. Themafority of the magnetic implant is long and thin except for the distaltip which contains a knob 140 similar to the previous embodiment. Mostof the length of the magnetic implant resides on the side of theendoscope except for the leading edge containing the knob. As comparedto the previous embodiment where the implant was completely in front ofthe scope, placing the implant in this position may allow the operator abetter field of view as the implant cannot be blocking the view whilegaining access to the target anastomosis location. However, thedisadvantage is that the implant will increase the overall profile ofthe endoscope making it potentially more difficult to push throughnarrow regions such as the pylorus or ileocecal valve. A retentionfeature 158 may be attached to the outside of the endoscope 132 toprevent the proximal end of the implant 136 from bending away from theendoscope during retrograde movement of the endoscope. For instance, theproximal end of the implant may catch on the vessel wall or otheranatomical features during retrograde movement. Similar to the previousembodiment, FIG. 16 b illustrates that the implant 136 can be movedaxially from the distal tip of the endoscope 132 Likewise, the endoscopeis pre-assembled in similar fashion to the previous embodiment in that adelivery catheter 134 is loaded into the working channel 138 of theendoscope 132 and the magnetic implant 136 is releasably attached to thedistal end of the delivery catheter 34 using a snare 142 that is wrappedaround a knob feature 140 integral to the magnetic implant 36. FIG. 16 cillustrates unlocking the snare wire 142 and releasing the magneticimplant 136.

FIG. 17 shows a cross section of the distal portion of the endoscopicdelivery device 130 in its locked condition. Similar to the previousembodiment, the magnetic implant 136 consists of a magnet 144 andhousing 146. The housing consists of a top 148 a and bottom 148 b. Thetop 148 a contains a knob feature 140 for holding onto the magneticimplant 136 with a snare 142. Although an external means for releasablyattaching the implant to the delivery catheter using a knob feature hasbeen shown, an implant housing is contemplated with internal releasableattachment features. As previously described, the magnetic implantincorporates rounded atraumatic features for ease of tracking the devicethrough the body lumen prior to coupling and after the anastomosis hasbeen created when the implant is exiting the body.

FIGS. 18 a-18 c show an alternative embodiment of an endoscopic deliverydevice 230 used according to the methods described previously to createa duodenum to transverse colon or ileum anastomosis. This embodiment issimilar to the previous embodiments except that the magnetic implantgeometry has changed to allow the implant to travel down the workingchannel of an endoscope instead of being pre-assembled at the distal endof the endoscope. One advantage of this embodiment as compared to theprevious embodiments is that the endoscope may access the targetanastomosis site in the duodenum and ileum or transverse colon withoutthe potential challenges of the delivery catheter or magnetic implantextending out of the distal tip of the endoscope or to the side of theendoscope. This may allow the operator to use the endoscopes without themagnetic implant potentially obstructing the view, or adding to theeffective diameter of the delivery device by the implant riding on theside of the scope, or adding to the overall stiffness of the endoscopeby having a delivery catheter in the working channel and an implantleading the endoscope as the operator attempts to articulate the distalend of the scope and navigate through the vessels. Preferably, theendoscope is advanced through the vessel to the target implant locationand the magnetic implant is subsequently advanced through the workingchannel to the distal tip of the endoscope. However advantageous it mayseem to advance the delivery catheter and magnetic implant to the distalend of the endoscope after it has reached its target location as justdescribed, the operator may pre-load the working channel with thedelivery catheter and magnetic implant and advance it to the distal tipof the endoscope prior to or while tracking the endoscope through thebody vessel to the target anastomosis location. Although the previouslydescribed embodiments may also work with advanced access tools, thisembodiment is more readily available to be used with single of doubleballoon enteroscopes or other overtube or externally applied devices toa standard endoscope for gaining access deep into the small bowel fromeither a nasal, oral, or anal access location.

FIG. 18 a illustrates that once the endoscope is navigated to the targetanastomosis location, the magnetic implant 236 has been introduced intothe endoscope 232 and advanced axially within the working channel 238 tothe tip of the endoscope. FIG. 18 b shows the implant 236 fully advancedout the endoscope 232 in a position for coupling. The implant isattached to the delivery catheter 234 by pulling a loop feature 260attached to the implant into the lumen of the delivery catheter using agrabber 242 that resides within the lumen of the delivery catheter. FIG.19. shows a detailed view of the connection of the magnetic implant 236to the distal end of the delivery catheter 234. The loop 260 isback-loaded into the delivery catheter 234 by inserting the loop in theU-shaped jaw of the grabber 242 and pulling the grabber and loop intothe delivery catheter. The height of the u-shaped feature isapproximately the same size as the inner diameter of the deliverycatheter so that the loop is trapped between the u-shaped jaw and theinner wall of the catheter. After the loop is pulled into the deliverycatheter, the grabber is pulled tight relative to the delivery catheterand locked in a handle set (not shown) that would be positioned at theproximal end of the delivery catheter. While pulling tight, the implant236 is rotated so the teeth 262 on the distal end of the deliverycatheter 234 mate and insert into the notch 264 on the implant. Theteeth transfer torque and rotation of the delivery catheter to theimplant while the grabber 242 couples the implant axially to thecatheter. These features allow the implant to be advanced axially androtated relative to the endoscope to aid with fine positioning of theimplant prior to and during coupling.

FIG. 18 c shows the implant 236 released from the delivery catheter 234.The grabber 242 is advanced distally relative to the delivery catheterso that the loop 260 is able to leave the U-shaped jaw of the grabber.FIG. 20. shows a detailed view of the distal end of the deliverycatheter and proximal end of the magnetic implant after release. Similarto the previous embodiments after release, the grabber 242 may recapturethe loop 260 if the implant 236 needs to be repositioned or removed fromthe body. Although an external means for releasably attaching theimplant to the delivery catheter using a loop feature has been shown, animplant housing is contemplated with internal releasable attachmentfeatures.

FIG. 21 shows the distal end of the endoscopic delivery device 230 invarious cross sections. Section C-C shows the width of the magnets whileSection D-D shows the thickness. FIG. 22 illustrates that the magneticimplant 236 is flexible so that it may be easily tracked through aflexible endoscope 232. The implant may consist of one magnet or severaldepending on the overall length of the desired implant and theflexibility needed to access the target anastomosis location. Thehousing 246 may be constructed of an implant grade polymer of adurometer (hardness) that allows it to bend as shown. It may befabricated and assembled by starting with an extrusion and assemblingthe magnets into the extrusion, or the magnets may be insert molded. Ifinsert molded, the polymer used should have melt temperature that doesnot degrade the magnetic properties of the magnet. The housing may alsobe fabricated out of an implant grade metal if the implant itself doesnot need to be flexible; however, it can be envisioned that a series ofindividual magnet are encapsulated in a metal housing could be attachedin series with a cable, ribbon, or hitch feature coupling them alltogether where the ribbon or cable flexed so that the train of magnetscould navigate a tortuous path. The ribbon or cable linking the seriesof magnets would preferably transfer rotational and axial movement froma releasably attached delivery catheter. As previously described, theimplant incorporates rounded atraumatic features for ease of trackingthe device into the body lumen prior to coupling and after theanastomosis has been created when the implant is exiting the body. Theimplant may be coated with a lubricious coating to aid in tracking downthe lumen of the endoscope. Similar to the previous embodiments, themagnets are preferably neodymium rare earth magnets. The notched collar264 and loop 260 may be insert molded into the housing or separatelyattached by reflowing them into the polymer of the housing or bondingthem to the housing. The collar may be integrated into the housinginstead of a separate component. The loop may be fabricated out ofimplant grade braided wire, solid wire, or nitinol wire. It may also befabricated out of implant grade monofilament or braided polymer line.

FIG. 23 a shows an alternative attachment device for grabbing the loop260 on the magnetic implant 236. In this figure, a mechanically actuatedjaw grabber 266 is used to grab the loop instead of the grabber 242shown in previous figures. The grabber has a slot cut through it toaccept the loop. Similarly, the grabber 266 pulls the loop into thedelivery catheter 234 and the teeth 262 slide into the slot 264 on theimplant to transfer the torque as previously described. FIG. 23 b showsthe implant 236 released from the jaws of the grabber 242.

FIGS. 24 a-24 c show another variation of the previously describedembodiment. This embodiment shows a different delivery catheter 334 withdifferent releasable attachment features on the proximal end of themagnetic implant 336. This is to illustrate that there are manyvariations on how to releasably attach a thin magnetic implant thatslides down the working channel of an endoscope to a delivery catheter.Those skilled in the art will appreciate that any deviations from whatis shown would be encompassed in the spirit of the present invention.The difference in this variation is that the mechanically actuated jaw366 is permanently attached to the distal tip of the delivery catheter334 and does not slide within the lumen of the catheter. The torquetransmitting teeth 262 and slot 264 from the previous embodiment havebeen replaced with a slot 372 feature in the mechanically actuated jawand a mating bar 370 feature integrated into the housing 346 of themagnetic implant 336, respectively. The ball 368 feature integrated intothe housing 346 transmits axially movement of the catheter 334 to theimplant 336. FIG. 25 shows a detailed view of the distal tip of thecatheter 334 and the proximal end of the magnetic implant 336. The slot372 in the mechanically actuated jaw 366 is sized to mate and transmittorque to the bar 370 in the housing of the magnetic implant 336. Theball 368 and bar 370 may be bonded, molded, insert molded, or overmolded onto the housing. Although an external means for releasablyattaching the implant to the delivery catheter using a ball and barfeature have been shown, an implant housing is contemplated withinternal releasable attachment features

Since endoscopes have a wide range of working channel diameters. It maybe advantageous to use a scope with a rather small working channel. Thismay translate into using a small magnetic implant that might not haveenough strength to overcome the daily loads that the intestinal vesselsexperience from natural digestive processes and outside physical loads,therefore one magnetic implant may not give enough force or area toideally create the desired anastomosis or maintain implant coupling dueto internal or external loads. One aspect of the present invention isthat multiple magnetic implants may be used to increase the strengthand/or area of the anastomotic implant(s) in each vessel. FIG. 26 showsthat the magnetic implants of the previously and subsequently describedembodiments and variations may incorporate a second magnetic implantdeployed to the side of the first implant to increase the anastomosisarea and overall force clamping the vessels together at the anastomosissite. FIG. 27 shows a scenario where another magnetic implant 236 or 336is stacked on top of a previously deployed magnetic implant 236 or 336in the same vessel. This would double the force applied to create theanastomosis over the same area, therefore doubling the pressure on thetrapped tissue. FIG. 28 shows a scenario where magnetic implants 236 or336 have been stacked to the side and on top of previously appliedmagnetic implants. Magnetic implants may also be stacked in line (infront or behind) so that shorter implants could be placed in line tocreate a longer effective implant. The figures in no way illustrate allthe combinations that those skilled in the art could easily contemplate.

FIGS. 29 a-29 d show in stepwise fashion an embodiment of an endoscopicdelivery device deploying a magnetic implant from an overtube assembledto the outside of an endoscope. The endoscopic delivery device 430consists of a magnetic implant 436 releasably attached to a deliverycatheter 434 that axially and rotationally moves within a lumen in thewall of an overtube 474. The overtube, delivery catheter, and magneticimplant assembly are back-loaded onto the endoscope 432 prior toinserting into the body. This view shows the overtube 474 in a retractedposition away from the distal tip of the endoscope 432 allowing thearticulating portion of the endoscope to be free from constrainment ofthe overtube. This feature allows the operator the ability to freelynavigate through the body vessels without view obstruction of themagnetic implant 436 or hindrance of articulation of the endoscope. Agrasping device 478 releasably holds the magnet in a slot 476 on theovertube 474. The notch on the overtube provides further constrainmentof the magnet, especially in transferring torque and rotation to theimplant about the endoscope. FIG. 29 b illustrates that the overtube 474can be moved axially in relation to the endoscope 432. Once the operatorhas navigated the distal tip of the endoscope to the desired targetanastomosis location, the magnetic implant 436 is advanced to the tip ofthe endoscope 432 by moving the overtube 474 axially as shown. Theability to rotate the overtube about the endoscope allows the operatorto position the implant in any radial direction to aid in achievingmagnetic coupling with another magnetic implant in an adjacent vessel.FIG. 29 c illustrates the delivery catheter 434 telescoping the magneticimplant 436 distal to the tip of the endoscope 432 to aid in magneticcoupling to another implant in an adjacent vessel. Also, the implant maybe radially aligned by rotating the shaft of the delivery catheter. FIG.29 d shows the overtube 474, delivery catheter 434, and mechanicallyactuated jaw grabber 466 after the magnetic implant 436 has beenreleased. The mechanically actuated jaw grabber 466 is attached to thedelivery catheter 434. The delivery catheter 434 is located within alumen 478 in the wall of the overtube 474. The mechanically actuatedgrabber may be designed to releasably attach to a feature that isinternal or external to the magnetic implant. As described in theprevious embodiments, the delivery catheter may be coated with alubricious coating to aid in advancing down the lumen of the overtube.The inner diameter of the overtube may be coated to aid in advancing androtating the overtube about the endoscope. Also, the implant may becoated with a lubricious coating to aid in advancing through the bodyvessel. The coating may be a silicone or hydrophilic coating.

FIGS. 30 a-30 c show in stepwise fashion an alternative embodiment of anovertube endoscopic delivery device similar to the device previouslydescribed. This embodiment shows an overtube with a slot formed in thedistal tip to receive a small profile magnetic implant as previouslydescribed in FIGS. 18-25. The overtube also has a lumen within its wallto accept a delivery catheter as previously described. The endoscopicdelivery device 530 consists of a magnetic implant 536 releasablyattached to a delivery catheter 534 that axially and rotationally moveswithin a lumen 578 in the wall of an overtube 574. Similar to theprevious embodiment, the overtube, delivery catheter, and magneticimplant assembly are back-loaded onto the endoscope 532 prior toinserting into the body. FIG. 30 a shows the overtube 574 in a retractedposition away from the distal tip of the endoscope 532 allowing thearticulating portion of the endoscope to be free from constrainment. Theovertube 574 may be designed to integrate with any endoscope; however,the endoscope is preferably a gastroscope, colonoscope, or smalldiameter enteroscope. The distal end of the overtube is tapered totransition to the outer diameter of the endoscope. A balloon 580 may ormay not be incorporated at the tip of the overtube 574 to allow singleor double enteroscopy to aid in accessing target anastomosis locationsdeep with the bowel. As previously described in the embodiments,features within the delivery catheter and on the magnetic implantreleasably attach the implant to the delivery catheter. The deliverycatheter 532 holds the implant within the slot 576 of the overtube 574.As previously described, the slot on the overtube provides furtherconstrainment of the magnetic implant, especially in transferring torqueand rotation to the implant about the endoscope. Likewise, FIG. 30 billustrates the delivery catheter 534 telescoping the magnetic implant536 distal to the tip of the endoscope 532 to aid in magnetic couplingto another implant in an adjacent vessel. Also, the implant may beradially aligned by rotating the shaft of the delivery catheter. FIG. 30c shows the delivery catheter 534 and grabber 542 after the magneticimplant 436 has been released. The delivery catheter, grabber andattachment features on the implant are for illustrative purposes as anycombination of delivery catheter, grabber, and implant releasableattachment feature described in the previous embodiments may beincorporated as appropriate.

FIGS. 31 a-31 c show in stepwise fashion a variation of the previouslydescribed embodiment as shown in FIG. 30 a-30 c. The variation isdifferent in that the slot or channel extends the entire length of theovertube instead of only at the distal tip of the overtube. Also, thechannel is entirely within the wall of the lumen which allows themagnetic implant to be tracked along the entire length of the overtube.Similar to the previous embodiment, the overtube is back-loaded onto theendoscope 532 prior to inserting into the body, but the deliverycatheter and magnetic implant may be loaded in the channel prior toinserting into the body. It may be easier to articulate the endoscopeand navigate to the target anastomosis location without the increasedstiffness of the magnetic implant and delivery catheter near the distaltip of the endoscope; therefore, it may be preferable to advance theimplant and catheter after the target location is reached. However, itmay not be necessary and may be preferable in some cases to telescopeout of the distal tip to help introduce/guide the endoscope through theanatomy. Since the catheter and magnetic implant may be freely exchangedthrough the channel, the operator may deploy a second or multiplemagnetic implants at the target location without removing the endoscopesfrom the target location. FIG. 31 a shows the overtube 574 in aretracted position away from the distal tip of the endoscope 532. FIG.31 b illustrates the delivery catheter 534 telescoping the magneticimplant 536 distal to the tip of the endoscope 532 through the channel582 in the overtube 574. FIG. 31 c shows the variation after themagnetic implant has been released. As described in the previousembodiments, the delivery catheter may be coated with a lubriciouscoating to aid in advancing down the channel of the overtube. The innerdiameter of the overtube may be coated to aid in advancing and rotatingthe overtube about the endoscope. Also, the implant may be coated with alubricious coating to aid in advancing through the channel of theovertube. The coating may be a silicone or hydrophilic coating.

Although not preferred, another aspect of the invention for all theovertube embodiments is that the full profile of the overtube could beshorter and reside at the distal tip of the endoscope and not extend itsfull profile proximally out of the body. Instead, a smaller overtubeprofile just encompassing the delivery catheter could extend from theshort, full profile section at the distal end of the endoscopeproximally out of the body. Or, the overtube may only consist of ashort, full profile at the distal tip of the endoscope with only thedelivery catheter extending proximally out of the body.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. For example, though the devices described herein areoptimally designed for use in a probe, obviating the need for puncturingpatient tissue or making incisions, one skilled in the art willappreciate that these devices could be used in surgical or laparoscopicprocedures. Accordingly, it is to be understood that the drawings anddescriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

1. A method of creating an anastomosis comprising: navigating a firstprobe through the digestive tract of a patient via the esophagus to afirst target location in the duodenum of the patient; navigating asecond probe through the digestive tract of the patient via the rectumto a second target location in the bowel, naturally adjacent to theduodenum; establishing, without puncturing patient tissue, a magneticconnection between a first anastomosis-forming device carried by thefirst probe and a second anastomosis-forming device carried by thesecond probe; releasing said first and second devices from said firstand second probes.
 2. The method of claim 1 wherein navigating a firstprobe through the digestive tract of a patient via the esophagus to afirst location in the duodenum of the patient comprises navigating afirst endoscope through the digestive tract of a patient via theesophagus to a first target location in the duodenum of the patient. 3.The method of claim 1 wherein navigating a second probe through thedigestive tract of the patient via the rectum to a second targetlocation in the bowel, naturally adjacent to the duodenum comprisesnavigating a second endoscope through the digestive tract of the patientvia the rectum to a second target location in the bowel, naturallyadjacent to the duodenum.
 4. The method of claim 1 wherein the firsttarget location and second target location are sufficiently naturallyadjacent to allow said magnetic connection without manipulation ofeither target location.
 5. The method of claim 1 wherein establishing,without puncturing patient tissue, a magnetic connection between a firstanastomosis-forming device carried by the first probe and a secondanastomosis-forming device carried by the second probe comprisesaligning said first anastomosis-forming device with said secondanastomosis-forming device using visual guidance.
 6. The method of claim1 wherein establishing, without puncturing patient tissue, a magneticconnection between a first anastomosis-forming device carried by thefirst probe and a second anastomosis-forming device carried by thesecond probe comprises aligning said first anastomosis-forming devicewith said second anastomosis-forming device using fluoroscopic guidance.7. A method of creating an anastomosis comprising: navigating a firstendoscope through the digestive tract of a patient via the esophagus toa first target location in the duodenum of the patient; navigating asecond endoscope through the digestive tract of the patient via therectum to a second target location in the bowel, naturally adjacent tothe duodenum; advancing through a working channel of said firstendoscope, a first elongate anastomosis-forming device; advancingthrough a working channel of said second endoscope, a second elongateanastomosis-forming device; establishing a magnetic connection betweensaid first and second anastomosis-forming devices; releasing said firstand second devices from said first and second endoscopes.
 8. The methodof claim 7 wherein establishing a magnetic connection between said firstand second anastomosis forming devices comprises aligning said first andsecond anastomosis forming devices across tissues from said duodenum andsaid bowel such that a magnetic attraction occurs between said devices.9. The method of claim 8 wherein aligning said first and secondanastomosis forming devices across tissues from said duodenum and saidbowel such that a magnetic attraction occurs between said devicescomprises visually aligning said first and second anastomosis formingdevices across tissues from said duodenum and said bowel such that amagnetic attraction occurs between said devices.
 10. The method of claim8 wherein aligning said first and second anastomosis forming devicesacross tissues from said duodenum and said bowel such that a magneticattraction occurs between said devices comprises fluoroscopicallyaligning said first and second anastomosis forming devices acrosstissues from said duodenum and said bowel such that a magneticattraction occurs between said devices.
 11. A device for forming asubstantially round anastomosis having a radius (r) comprising: a firstelongate component having a length (l) and a width (w); and, a secondelongate component magnetically attracted to said first component andhaving a length (l) and a width (w); wherein width (w) is narrow enoughto fit within a working channel of a standard endoscope; and, whereinlength (l) is related to a desired radius (r) of a resulting,substantially round anastomosis according to the formula (l)=(Π)(r)−(w).12. The device of claim 11 wherein (w) is less than 7 mm.
 13. The deviceof claim 12 wherein (w) is between 1.5 mm and 7 mm.
 14. The device ofclaim 13 wherein (w) is between 1.5 mm and 3.7 mm.
 15. A system forforming an anastomosis in a digestive tract of a patient comprising:first and second probes, each probe defining at least one lumenslidingly housing an attachment mechanism and each probe having an opticlens; a first device carried by said first probe and attached thereto bysaid attachment mechanism, said first device comprising: a magnet; ahousing at least partially encasing said magnet, said housing defining aconnector releasably and repeatably engageable by said attachmentmechanism; a second device carried by said second probe and attachedthereto by said attachment mechanism, said second device comprising; anelement attracted to said magnet of said first device; a housing atleast partially encasing said element, said housing defining a connectorreleasably and repeatably engageable by said attachment mechanism. 16.The system of claim 15 wherein: said first device has a length (l) and awidth (w); wherein width (w) is narrow enough to fit within a workingchannel of a standard endoscope; and, wherein length (l) is related to adesired radius (r) of a resulting, substantially round anastomosisaccording to the formula (l)=(Π)(r)−(w).
 17. The device of claim 16wherein (w) is less than 7 mm.
 18. The device of claim 17 wherein (w) isbetween 1.5 mm and 7 mm.
 19. The device of claim 18 wherein (w) isbetween 1.5 mm and 3.7 mm.
 20. The device of claim 15 wherein saidconnector comprises a knob.
 21. The device of claim 15 wherein saidconnector comprises a loop.
 22. A method of forming a round anastomosiscomprising: positioning two devices on either side of a desiredanastomosis site such that tissue is compressed between said twomagnets; wherein each of said devices comprises a single elongate magnethaving a length that is approximately half of a desired circumference ofa resulting anastomosis; wherein each of said devices has a width ofless than 7 mm.
 23. The method of claim 22 wherein each of said deviceshas a width in the range of 1.5 mm to 7 mm.
 24. The method of claim 22wherein each of said devices has a width in the range of 1.5 mm to 3.7mm.